(227 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a lubricant, with no mention of AI or ML technologies.
No.
The device is intended to moisturize and lubricate to enhance comfort during intimate sexual activity and supplement natural lubrication, which is not considered a therapeutic purpose.
No
The device is described as a personal lubricant and moisturizer intended to enhance comfort during sexual activity, not for diagnosing any condition.
No
The device is a physical gel product intended for vaginal application, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for vaginal application to moisturize and lubricate, enhancing comfort during intimate sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The description details the physical characteristics and composition of the gel, its packaging, and its compatibility with condoms. There is no mention of it being used to test for or diagnose any condition.
- Lack of Diagnostic Function: IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform any such analysis.
- Performance Studies: The performance studies focus on biocompatibility, antimicrobial effectiveness, condom compatibility, and shelf life – all related to the physical and safety aspects of a personal lubricant, not diagnostic accuracy.
Therefore, Luvena Vaginal Moisturizer and Lubricant is a medical device, but it falls under the category of a personal lubricant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Luvena Vaginal Moisturizer and Lubricant is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Luvena Vaginal Moisturizer & Lubricant is non-sterile, translucent, non-staining, non-greasy, aqueous-based, cranberry-flavored gel and is packed in EVA/PE copolymer plastic applicator tube. Each application tube is single-use. It is for personal vaginal use as need for moisturizing and lubrication during intimate sexual activity.
This device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to ASTM D7661-10.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal application
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility of the final formulation of Luvena Vaginal Moisturizer & Lubricant was established through testing generally following ISO 10993, and includes cytotoxicity, sensitization, irritation, and acute systemic toxicity testing. The results demonstrate that the subject lubricant is biocompatible.
- Acute Systemic Toxicity: ISO 10993-11:2006
- Cytotoxicity: ISO 10993-5:2009
- Vaginal Irritation Testing: ISO 10993-10:2010
- Sensitization Testing Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010.
The physical and other testing performed on Luvena Vaginal Moisturizer & Lubricant included an Antimicrobial Preservative Effectiveness Validation testing under USP Category 2. Lubricant- Condom Compatibility testing per ASTM D7661 - 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms and Shelf life testing. Luvena Vaginal Moisturizer and Lubricant passed the Antimicrobial Effectiveness test and were found to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms. The results of accelerated time testing and real time testing according to ICH-Q1A (Stability testing of new drug substances and products) and ICH-Q1E (Evaluation of stability data) support the proposed shelf life for the subject lubricant.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right, with a design element below them that resembles flowing water or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Laclede, Inc. Michael Pellico President 2103 E. University Dr. Rancho Dominguez, CA 90220
Re: K162235
Trade/Device Name: Luvena Vaginal Moisturizer and Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 21, 2017 Received: February 24, 2017
Dear Michael Pellico:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image shows the name "Charles Viviano -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. There is a faint, light blue watermark in the background that is partially obscured by the text.
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K162235
Device Name
Luyena Vaginal Moisturizer and Lubricant
Indications for Use (Describe)
Luyena Vaginal Moisturizer and Lubricant is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
3
510 (k) Summary
| Submission By: | Laclede, Inc. |
|---|---|
| Address: | 2103 E. University Drive |
| Rancho Dominguez, Ca 90220 | |
| Telephone: | 310-605-4280 |
| Facsimile: | 310-605-4288 |
| Contact Name: | Michael A. Pellico, President |
| Email: | mpellico@laclede.com |
Date 510(k) Summary Prepared: March 23, 2017
| Trade Name: | Luvena Vaginal Moisturizer & Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 C.F.R. 884.5300) |
| Classification: | Class II |
| Product Code: | NUC (lubricant, personal) |
Primary Predicate Device:
Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant: K150841, Laclede, Inc. This predicate device has not been subject to any design related recall.
Device Description:
Luvena Vaginal Moisturizer & Lubricant is non-sterile, translucent, non-staining, non-greasy, aqueous-based, cranberry-flavored gel and is packed in EVA/PE copolymer plastic applicator tube. Each application tube is single-use. It is for personal vaginal use as need for moisturizing and lubrication during intimate sexual activity.
This device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to ASTM D7661-10.
Device Specifications:
The device specifications for the Luvena Vaginal Moisturizer and Lubricant include appearance, odor, pH, viscosity, osmolality, Total Aerobic Microbial Count ((TAMC) (USP and )), Total Yeast and Mold Count ((TYMC) (USP and )), and absence of pathogenic organisms ((Pseudomonus aeruginosa, Staphylococcus aureus, Candida albicans (USP)). These specifications were evaluated during the length of the proposed shelf life.
Intended Use:
Luvena Vaginal Moisturizer and Lubricant is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with
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natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.
Substantial Equivalence:
Luvena Vaginal Moisturizer & Lubricant have the same intended use as the predicate device. However, the subject moisturizer & lubricants and the predicate device have different technological characteristics – namely differences in viscosity, formulation and package type. These differences do not raise different questions of safety & effectiveness.
| Features | Luvena Vaginal
Moisturizer &
Lubricant | Luvena Enhanced Personal
Moisturizer and
Luvena Enhanced Personal
Lubricant
K150841 | Differences |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Water Based | Yes | Yes | Same, The subject and
predicate device are water
based |
| Water Soluble | Yes | Yes | Same, The subject and
predicate device are soluble in
water |
| Non Sterile | Yes | Yes | Same, The subject and
predicate device are non-sterile. |
| Flavoring | Cranberry | Cranberry | Same, The subject and
predicate device have same
flavoring. |
| Container Type | Single use Applicator | Bottle with pump | The subject and predicate
device are different size and
shape for OTC packaging, but
these differences have no
impact on the safety or efficacy
of the personal lubricant. |
| Condom
compatibility | Yes
ASTM D7661-10
Compatible with
natural rubber latex
and polyisoprene
condoms, and not
compatible with
polyurethane
condoms. | Yes
ASTM D7661-10
Compatible with natural
rubber latex and
polyisoprene condoms, and
not compatible with
polyurethane condoms. | Same, The subject and
predicate device have been
tested for condom compatibility
in accordance with ASTM
D7661-10. |
| pH | Yes
3.8 - 4.8 | Yes
3.8 - 4.8 | Same, The subject and predicate
device have same pH range. |
| Microbiological
Examination of
Non-sterile
Products Testing | USP / | USP / | Same, The subject and predicate
device have been tested for
Microbial Limit test in
accordance with USP and
and have same
specifications as recommended
in USP for vaginal use |
| | | products. | |
| Body Location
Target area | Vaginal application | Penile and/or
Vaginal application | Same, Subject and predicate device are for Vaginal application. |
| Intended Use | Moisturize & Lubricate during sexual activity | Moisturize & Lubricate during sexual activity | Same, Subject and predicate device have same intended use. |
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Biocompatibilitv:
Biocompatibility of the final formulation of Luvena Vaginal Moisturizer & Lubricant was established through testing generally following ISO 10993, and includes cytotoxicity, sensitization, irritation, and acute systemic toxicity testing. The results demonstrate that the subject lubricant is biocompatible.
- · Acute Systemic Toxicity: ISO 10993-11:2006
- · Cytotoxicity: ISO 10993-5:2009
- · Vaginal Irritation Testing: ISO 10993-10:2010
- · Sensitization Testing Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010.
Physical & Other Testing:
The physical and other testing performed on Luvena Vaginal Moisturizer & Lubricant included an Antimicrobial Preservative Effectiveness Validation testing under USP Category 2. Lubricant- Condom Compatibility testing per ASTM D7661 - 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms and Shelf life testing. Luvena Vaginal Moisturizer and Lubricant passed the Antimicrobial Effectiveness test and were found to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms. The results of accelerated time testing and real time testing according to ICH-Q1A (Stability testing of new drug substances and products) and ICH-Q1E (Evaluation of stability data) support the proposed shelf life for the subject lubricant.
Conclusion:
The subject and predicate device have the same intended use and the different technological characteristics do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.